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- Title
Patient-focused drug development programme takes first steps.
- Authors
Mullard, Asher
- Abstract
The article focuses on the patient-focused drug development programme initiated by the U.S. Food and Drug Administration (FDA) with the implementation of the fifth Prescription Drug User Fee Act (PDUFA V) in 2012. The programme includes 20 meetings with different groups of patient by 2017 wherein the first three meetings were held for patients with chronic fatigue syndrome (CFS), lung cancer, and myalgic encephalomyelitis (ME). It notes that the meetings informs on new benefitrisk framework.
- Subjects
UNITED States; DRUG development; HEALTH programs; UNITED States. Food &; Drug Administration; CHRONIC fatigue syndrome; PHARMACEUTICAL policy; PATIENTS
- Publication
Nature Reviews Drug Discovery, 2013, Vol 12, Issue 9, p651
- ISSN
1474-1776
- Publication type
Article
- DOI
10.1038/nrd4104